Technology, governance and patient safety: Systems issues in technology and patient safety
Introduction
Publication of the U.S. Institute of Medicine's 1999 report To Err is Human [1] ignited concern about healthcare error and patient safety. Since publication of the report, much attention has been focused on adverse events (AEs), including medical error that compromises patient safety. Factors viewed as contributing to patient safety problems include rapid changes in the health care system, increased use of technology, the quickening pace of work [2] and the increased complexity of technology. In Canada there are few coordinated and systematic processes to collect information about adverse events and errors [3]. Data from the U.S. suggests that technical complications accounted for 13% of adverse events, making technical complications the third largest category of adverse event [4].1 A UK publication [5] reported that 400 people die annually in the UK from adverse events related to medical devices. Other sources [6] report that equipment failure was responsible for between one fifth and one half of all adverse events. Adverse events related to technology may be reported a number of different ways (e.g., as technical complications, as operator/user error, etc.), hence equipment related adverse events may be under-reported [7] especially if adverse events considered human errors related to poor design of work (including person-task-equipment interactions) are not taken into account [4].
Breakdowns in health care services have caused considerable harm to patients and have often persisted unchecked for extended periods of time. What is striking is “that major failures are not usually brought to light by the systems for quality assurance or improvement” ([8]: 107). Here we synthesize literature concerned with adverse medical events and technology with an aim of providing a starting point for the development of conceptual tools that will support development of governance processes and approaches to minimize the occurrence of such adverse events related to technology and medical devices. The research reported here is designed to increase our understanding of errors and adverse events involving technology and medical devices, improve our knowledge of health technology governance processes, and provide a starting point for consideration of the effectiveness of various policy instruments in reducing adverse events and medical errors.
In discussing medical device and technology errors, we use the terms technology and medical device interchangeably. Although our broad understanding of technology mirrors that of Bush [9]2 in this context we also rely on the Council Directive 93/42/EEC [10] definition:
“‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
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diagnosis, prevention, monitoring, treatment or alleviation of disease,
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diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
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investigation, replacement or modification of the anatomy or of a physiological process,
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control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.” (p. 6)
Initial findings from our preliminary review of the literature which has focused on developing an understanding of how error is distributed over various points in the medical device and technology lifecycle are presented here. Given our broader concern with the relationship between governance of medical devices and patient safety, we discuss technology-related adverse events and errors in relation to medical device governance.
We begin by setting the stage for our discussion though an overview of technology, equipment, devices and medical error and adverse events, and of the governance of equipment, devices and technology (Section 2). We then outline some of the methodological challenges we have encountered in our efforts to complete a systematic review of adverse events related to medical devices, equipment and technology (Section 2). Variation in how technology and adverse events are measured and differences in schemes for measurement of adverse events related to technology reflect the complexity of health systems, where it is often difficult to assign causality. Consequently, it is difficult to establish the prevalence of technology related adverse events in health settings—a point we return to subsequently in our discussion.
In our results section (Section 4), we discuss stakeholders involved in medical device governance, and classification systems that form the backbone of medical device governance. We address the governance of medical devices across the device lifecycle (pre-market, placing a product on the market and post-market surveillance) in order to highlight the range of actors involved in medical device governance, and the distributed nature of device governance. In addressing patient safety issues, emphasis has typically been placed on the sharp (or point of care end) of care, and the practitioners who deliver care [11] rather than the blunt end of care (where regulatory, administrative and organizational factors reside). “The blunt end of the system is the source of the resources and constraints” that form the practitioner's work environment [12], [13]. Our discussion of governance across the medical device lifecycle serves to highlight the complexities of activities that occur at the blunt of care.
After briefly addressing inadequately governed areas, building on material included earlier in the paper we both synthesize issues related to the measurement of adverse events, and summarize data we have been able to locate about the prevalence of technology related adverse events. We argue that medical device governance processes reflect a framing of error as flowing from devices and users, rather than from socio-technical systems, and that a socio-technical framing of medical error can both contribute to a framing of device related errors as systems issues, and lead to improved medical device governing practices.
Section snippets
Technology, equipment, devices and medical error and adverse events
Although technology and equipment are often identified as contributors to several types of adverse events (e.g., equipment is seen as a performance shaping factor, as well as a situational or procedural problem), technology is seldom identified as the source of medical error or adverse event in adverse event investigations [4]. Rather, technology (e.g., computerized physician order entry systems, automated drug dispensing systems) is seen as both a means of reducing error (by reducing
Methodological issues
Work reported here was undertaken during the early stages of a systematic review of the published and gray literature concerned with governance of health technology and patient safety. Although our intention at the onset of our research was to complete a review that would address the incidence of medical device errors and governance issues that occur in several countries, the use of inconsistent means of measuring device and technology related adverse events makes a traditional systematic
Results—governance of medical devices
A number of actors (or stakeholders) interact in complex regulatory environments in which medical devices are produced and used, and in which errors occur. In this section we identify some of the actors in the network of relations that constitute medical device regulation. We then turn to regulation of medical devices, beginning with an overview of systems of classification that serve as a foundation for medical device regulation. We provide an overview of the lifecycle of medical devices, and
Discussion and conclusion
As Beatty [41] pointed out, To Err is Human [1] suggested that human error causing adverse events are largely organizational, and related to factors such as ineffective training. Beatty suggests that for Samore et al. [7] this means that technology plays at best a minor role in the causality of adverse events. Although technology is often seen as a potential solution to adverse events, “you cannot engineer your way out of the problem because you cannot anticipate all the human failure modes” (
Acknowledgment
Work reported here has been funded by Health Canada, under RFP 14 titled Health technology, governance and patient safety: An overview and synthesis of the literature, Application 6795-15-2003/576002.
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